BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 11703797 · Received April 21, 2021

    Report

    Report Number
    1314492-2021-01361
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 5, 2021
    Report Date
    August 26, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS REPORTED STATING THE DEVICE WAS SWAPPED OUT AND THE VOLUME INFUSED CORRECTLY ON THE REPLACEMENT PUMP. H10: THE USER FACILITY SUBMITTED MEDWATCH (B)(4) FOR THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTED INFORMATION H6: PREVIOUSLY REPORTED DEVICE CODE A160102 IS REPLACED BY A160105.

    Additional Manufacturer Narrative · 1

    THE PRODUCT CODE WAS REPORTED AS 35700. INITIAL REPORTER FACILITY NAME: (B)(6). THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WAS NOT INFUSING ADEQUATELY DURING THERAPY (MEDICATION, DOSE, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN) IN THE MEDICAL INTENSIVE CARE UNIT. IT WAS REPORTED THAT THE PATIENT WAS INTUBATED AND WAS HAVING MANY PERIODS OF AGITATION WHILE ON DEXMEDETOMIDINE DRIP. THE NURSE KEPT ADDING VOLUME ON THE PUMP BUT THE VOLUME WAS NOT DECREASING IN THE BOTTLE. ADDITIONALLY, THE PUMP VOLUME WOULD READ ZERO (0) BUT VOLUME IN THE BAG REMAINED UNCHANGED. THE PATIENT OUTCOME WAS NOT NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600640 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other PRECEDEX